BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇾 Malaysia

    NON-CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES

    K Number: K942855 · Decision Nov 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    3
    Review Days
    517

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    Basic Information

    Device Name
    NON-CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES
    K Number
    K942855
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Evergrade Healthcare Products Sdn Bhd
    Date Received
    June 16, 1994
    Decision Date
    November 15, 1995
    Product Code
    LYY
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LYY Latex Patient Examination Glove

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    Other Clearances by Evergrade Healthcare Products Sdn Bhd

    K Number Device Name
    K973664 LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING
    K932116 PATIENT EXAMINATION GLOVES (POWDER FREE)